For approximately the past 20 years, the labeling of containers for blood components, including whole blood, has been in accordance with requirements set forth by the United States Food and Drug Administration in 1985 in “Guidance for Uniform Labeling of Blood Components,” incorporated by reference herein. In accordance with the 1985 guidance, labeled blood component containers have contained machine-readable information in a format in accordance with ABC Codabar Bar Code Symbology. The ABC Codabar was a format originally proposed by the American Blood Commission (“ABC”) and recognized by the Food and Drug Administration in 1985 as the only currently approved machine-readable symbology for use in blood component labeling in the United States. Labels pursuant to ABC Codabar format have included a bar code that includes a description of the container type and a bar code that includes the product code information assigned by the Food and Drug Administration for the intended contents of the container, for example whole blood, red blood cells or platelets and other components.
The International Society for blood transfusion (ISBT) recognized that the ABC Codabar had reached the end of its useful life and approved a new ISBT Code 128 Bar Code Labeling specification for blood products. The ISBT Bar Code labeling standard is based on the Code 128 symbology, which is different bar code format than the ABC Codabar symbology, and includes improvements in security, to reduce reading errors, to provide additional information and other improvements.
In October 2005, the American Association of Blood Banks (the “AABB”) committed to the use of new standards for blood component container labeling, as set forth in “United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components using ISBT 128”, also incorporated by reference herein. The deadline for implementation of ISBT 128 by AABB accredited facilities is May 1, 2008.
Although the AABB has selected a deadline of May 1, 2008 for implementation by accredited facilities, it is contemplated that not all facilities will adopt the ISBT 128 standard simultaneously. Instead, different blood banks will convert to the ISBT 128 Standard at different times. For this reason, it is anticipated that the co-existence of both types of bar coding systems for blood component containers will persist for a substantial period of time, as blood banks transition from the earlier ABC Codabar system to the new ISBT 128 System.
For manufacturers of blood component containers and users of such containers who are transitioning from the ABC Codabar to the ISBT 128 Standard, efficient inventory management and quality control issues and difficulties may arise from the need to maintain separate inventories of blood component containers, some of which are based on the ABC Codabar Symbology and others of which are based on the ISBT 128 Standard. For a user that switches from ABC Codabar to ISBT 128, there may be wasted inventory of previously purchased blood component containers using the ABC Codabar Symbology. For manufacturers, the manufacturer of the same blood component container with different labels creates serious logistical issues. The manufacturer must duplicate inventory and manage distribution to the appropriate individual purchasers, which will vary because different purchasers will be employing different systems or be at different stages of conversion from the ABC Codabar system to the ISBT 128 system.
As a result, there is a need for blood component containers that do not suffer from the drawbacks described above and allow for a ready and relatively painless transition from the earlier ABC Codabar System to the new ISBT 128 System by both users and manufacturers.